Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0779-2018·Announced 2018-05-16

Kroger Specialty Pharmacy Recalls Xalkori Capsules Due to Processing Control Issues

Kroger Specialty Pharmacy is recalling Xalkori 250 mg capsules due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or significant injuries are reported in the source text, aligning with the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

Kroger Specialty Pharmacy, Inc. is recalling Xalkori 250 mg capsules (NDC 00069-8140-20, 30-day supply) due to a lack of processing controls. The recall covers all lots remaining within their expiry date that were dispensed between December 1, 2017, and February 12, 2018.

The affected products were distributed in Mississippi, Louisiana, Arkansas, Illinois, and Florida. The source text does not specify the exact number of units recalled or report any illnesses or injuries associated with the product.

Consumers who have this medication should contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Xalkori 250 mg cap NDC 00069-8140-20 30 days supply
Manufacturer: Kroger Specialty Pharmacy, Inc.
Category: Drug — Prescription Medication
Hazard: processing-control-deficiency

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 67 recalled by Kroger Specialty Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

Same manufacturer · Kroger Specialty Pharmacy, Inc.

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